JPH023169Y2 - - Google Patents
Info
- Publication number
- JPH023169Y2 JPH023169Y2 JP1983100450U JP10045083U JPH023169Y2 JP H023169 Y2 JPH023169 Y2 JP H023169Y2 JP 1983100450 U JP1983100450 U JP 1983100450U JP 10045083 U JP10045083 U JP 10045083U JP H023169 Y2 JPH023169 Y2 JP H023169Y2
- Authority
- JP
- Japan
- Prior art keywords
- endotoxin
- endotoxin detection
- tube
- reagent
- measurement tool
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired
Links
- 238000005259 measurement Methods 0.000 claims description 23
- 238000001514 detection method Methods 0.000 claims description 19
- 239000002158 endotoxin Substances 0.000 claims description 18
- 239000012481 endotoxin detection reagent Substances 0.000 claims description 13
- 239000003153 chemical reaction reagent Substances 0.000 claims description 8
- 239000006166 lysate Substances 0.000 claims description 6
- 241001529572 Chaceon affinis Species 0.000 claims description 5
- 102000010911 Enzyme Precursors Human genes 0.000 claims description 3
- 108010062466 Enzyme Precursors Proteins 0.000 claims description 3
- 239000003086 colorant Substances 0.000 claims description 2
- 239000007788 liquid Substances 0.000 description 18
- 239000007864 aqueous solution Substances 0.000 description 5
- 238000000034 method Methods 0.000 description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 3
- 238000011109 contamination Methods 0.000 description 2
- 239000002510 pyrogen Substances 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 1
- 241000239218 Limulus Species 0.000 description 1
- 241000283973 Oryctolagus cuniculus Species 0.000 description 1
- 239000004793 Polystyrene Substances 0.000 description 1
- 210000000601 blood cell Anatomy 0.000 description 1
- 210000002421 cell wall Anatomy 0.000 description 1
- 239000012295 chemical reaction liquid Substances 0.000 description 1
- 230000015271 coagulation Effects 0.000 description 1
- 238000005345 coagulation Methods 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 238000004108 freeze drying Methods 0.000 description 1
- 238000001879 gelation Methods 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 230000020169 heat generation Effects 0.000 description 1
- 229920006008 lipopolysaccharide Polymers 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 230000001766 physiological effect Effects 0.000 description 1
- 229920003229 poly(methyl methacrylate) Polymers 0.000 description 1
- 239000004926 polymethyl methacrylate Substances 0.000 description 1
- 229920002223 polystyrene Polymers 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
Landscapes
- Investigating Or Analyzing Non-Biological Materials By The Use Of Chemical Means (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Apparatus Associated With Microorganisms And Enzymes (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
Description
【考案の詳細な説明】
本考案はエンドトキシンの検出測定用具に関す
るものである。[Detailed Description of the Invention] The present invention relates to an endotoxin detection and measurement tool.
エンドトキシンはグラム陰性菌の細胞壁中に存
在するリポ多糖と云われており、極めて微量で発
熱性をはじめ多種多様な生理活性を有する。 Endotoxin is said to be a lipopolysaccharide present in the cell walls of Gram-negative bacteria, and has a wide variety of physiological activities including pyrogenicity in extremely small amounts.
近年、医療、製剤、衛生の分野で、これに汚染
された医療器具、製剤の使用により生体の発熱が
問題になり、その検出測定が最終製品はもちろん
製造工程でも頻繁に行なわれている。 In recent years, in the fields of medicine, pharmaceutical preparations, and hygiene, heat generation in living organisms has become a problem due to the use of contaminated medical instruments and preparations, and its detection and measurement are frequently performed not only in final products but also in the manufacturing process.
エンドトキシンの検出法の１つとしてカブトガ
ニの血球抽出成分（アメイボサイトライセート）
またはこのライセートより分離された酵素前駆体
と発色剤を利用したリムルステストがある。この
方法は従来のウサギ発熱性試験で行なう方法に比
較してエンドトキシンを極めて迅速に検出できる
優れた方法であり、この方法に基いた各種のエン
ドトキシン検出測定用具が市販されている。 Horseshoe crab blood cell extract (ameibocyte lysate) is used as a method for detecting endotoxin.
Alternatively, there is a limulus test that uses an enzyme precursor isolated from this lysate and a coloring agent. This method is an excellent method that allows endotoxin to be detected extremely quickly compared to the conventional rabbit pyrogenicity test, and various endotoxin detection and measurement tools based on this method are commercially available.
しかし、従来の検出測定用具を用いた水溶液中
のエンドトキシンの検出測定では、測定用具とし
て反応容器の他にエンドトキシンフリーの検体液
採取器例えばピペツトや注射器等を用意しなけれ
ばならず、この採取器の用意に大変手間と時間を
要する。またその操作中にエンドトキシンによる
汚染の危惧もあるため測定環境に充分に注意を払
わねばならない等非常に繁雑である。 However, in the detection and measurement of endotoxin in an aqueous solution using conventional detection and measurement tools, it is necessary to prepare an endotoxin-free sample liquid collector, such as a pipette or syringe, in addition to the reaction container as a measurement tool. It takes a lot of time and effort to prepare. Furthermore, since there is a risk of contamination with endotoxin during the operation, it is very complicated and requires careful attention to the measurement environment.
本考案者らはこの様な点を簡便にする用具につ
いて鋭意検討した結果、エンドトキシン検出試薬
を保持した反応容器を検体液採取器に兼用するこ
とを思いつき、更にその器の形状等について検討
を重ねた結果、両末端を封じた細管状でかつ検出
測定時に両末端を開口出来る透明な容器が好都合
であることを見い出し先に出願した。（実願昭58
−49492号）
これに示された検出測定用具は簡便でしかも実
用上も優れたものであるが、常に一定量の検体液
を細管内に導入することが難かしい。そこで細管
に検体液導入量を示す計量目盛を付すことで、簡
単に一定量の検体液を細管内に導入でき、その結
果正確でしかも再現性良い検出結果が得られるこ
とを見い出して本考案に到達した。 The inventors of the present invention conducted extensive research into devices that would simplify these points, and came up with the idea of using the reaction container holding the endotoxin detection reagent as a sample liquid collector, and further considered the shape of the container, etc. As a result, they discovered that a transparent container with a tubular shape with both ends sealed and with both ends open during detection and measurement was advantageous, and the applicant filed an application. (Jitsugan 1984
-49492) Although the detection and measurement tool shown in this publication is simple and excellent in practical terms, it is difficult to always introduce a constant amount of sample liquid into the capillary. Therefore, we discovered that by attaching a measuring scale to the capillary tube to indicate the amount of sample liquid introduced, we could easily introduce a fixed amount of sample liquid into the tube, and as a result, we could obtain accurate and reproducible detection results, and developed this invention. Reached.
即ち、本考案は計量目盛を付した透明細管内部
にエンドトキシン検出試薬を封入して成るエンド
トキシン検出測定用具に関する。 That is, the present invention relates to an endotoxin detection and measurement tool comprising an endotoxin detection reagent sealed inside a transparent capillary with a measuring scale.
本考案における透明細管としては例えば、ガラ
ス、ポリメチルメタクリレート、ポリスチレン等
にて作られてものであり、その管内に存在する反
応液の状態が観察できる程度の透明性を有し、内
径0.1〜５mmのものが好都合に用いられる。 The transparent tube in the present invention is made of, for example, glass, polymethyl methacrylate, polystyrene, etc., has transparency to the extent that the state of the reaction liquid present inside the tube can be observed, and has an inner diameter of 0.1 to 5 mm. are conveniently used.
計量目盛とは細管内に検体液を導入する量を計
る目印で、細管の開口部と中央部との間に一本あ
るいは複数本付けられる。 A measuring scale is a mark for measuring the amount of sample liquid introduced into a capillary, and one or more scales are attached between the opening and the center of the capillary.
エンドトキシン検出試薬としては水溶液中のエ
ンドトキシンの検出に用いられる試薬であればど
のようなものも用いることができ、例えばカブト
ガニのアメイボサイトライセート、カブトガニの
アメイボサイトライセートより分離された凝固酵
素前駆体と発色剤の混合物を挙げることができ
る。 Any reagent used for detecting endotoxin in an aqueous solution can be used as the endotoxin detection reagent, such as horseshoe crab ameibocyte lysate, coagulation enzyme precursor isolated from horseshoe crab ameibocyte lysate, etc. and a color former.
また、保存安定性の観点から、これらは凍結乾
燥品が望ましく、試薬の安定化剤を添加してもよ
い。 In addition, from the viewpoint of storage stability, these are preferably freeze-dried products, and a stabilizer for the reagent may be added.
以下、図面でもつて説明する。 The drawings will also be explained below.
図はエンドトキシン検出測定用具の１例の断面
図である。 The figure is a sectional view of an example of an endotoxin detection and measurement tool.
１は両端を閉じた細管であり反応容器兼検体液
採取器として使用できる。図面では管内径は均一
となつているが、両端部または一方の端部が中間
部の管内径と異なつていてもよい。 Reference numeral 1 is a thin tube with both ends closed, and can be used as a reaction container and a sample liquid collector. Although the inner diameter of the tube is uniform in the drawings, the inner diameter of the tube at both ends or at one end may be different from the inner diameter of the intermediate portion.
また、図のように両末端を封管する代りに両端
が開口した細管を用いて、その開口端を適切な栓
で密封したものでもよい。 Further, instead of sealing both ends as shown in the figure, a thin tube with both ends open may be used, and the open ends may be sealed with a suitable stopper.
２は検出測定時の開口端で、細い管の端部が封
管されている場合はその位置が開口するように切
り離し易くするため例えば切傷をつける等の工夫
がなされていることが好ましい。開口端を適切な
栓で密封したものでは、２はその開口端である。 Reference numeral 2 denotes an open end during detection and measurement. If the end of the thin tube is sealed, it is preferable that a cut be made, for example, in order to make it easier to separate so that the end is open at that position. If the open end is sealed with a suitable stopper, 2 is the open end.
３は計量目盛で開口端からこの目盛まで検体液
を導入することで導入液量を一定にすることが出
来る。図面では線で示してあるが、点であつても
よく、また透明色の境界であつてもよい。 3 is a measuring scale, and by introducing the sample liquid from the open end to this scale, the amount of introduced liquid can be kept constant. Although shown as lines in the drawings, they may be points or transparent borders.
４はエンドトキシン検出試薬であり、図面で
は、管の中央部に充填されているが、計量目盛間
であれば何処に充填されていてもよい。 4 is an endotoxin detection reagent, which is filled in the center of the tube in the drawing, but may be filled anywhere between the measuring scales.
本考案のエンドトキシン検出測定用具は計量目
盛を付した内径0.1〜５mmの細管を準備し、別途
用意したエンドトキシン検出試薬の水溶液中にそ
の一端を挿入して細管内に水溶液を導入した後取
り出し、管を傾けるかあるいは他端から吸引して
管内の水溶液を中央部に移動させ、その状態で好
ましくは凍結乾燥で水を蒸発させることにより試
薬を細管内壁に固着させ、これをフイルム等の膜
状物で密封被包することにより得られる。このよ
うにして封入されたエンドトキシン検出試薬は細
管内壁に固着しているので輸送や保管・取扱い時
にはがれ落ちることはない。 The endotoxin detection and measurement tool of the present invention prepares a thin tube with an inner diameter of 0.1 to 5 mm with measuring scales, inserts one end of the tube into an aqueous solution of an endotoxin detection reagent prepared separately, introduces the aqueous solution into the thin tube, and then takes it out. The aqueous solution in the tube is moved to the center by tilting or suctioning from the other end, and in this state, the water is preferably evaporated by freeze-drying to fix the reagent to the inner wall of the tube, and the reagent is transferred to a membranous material such as a film. It can be obtained by hermetically encapsulating it. Since the endotoxin detection reagent encapsulated in this way is firmly attached to the inner wall of the capillary, it will not fall off during transportation, storage, or handling.
この様な測定用具では両端を開口させ、一端を
検体液に浸し、毛細管現象によりまたは他の端に
吸入具を付けて吸引することにより管内に検体液
を計量目盛まで導入し、エンドトキシン検出試薬
をその液で溶解させる。この検出試薬は水による
溶解性に優れるので端に乾燥した試薬に水が触れ
るだけで容易に溶解する。又、このようにして導
入された検体液は管が細いため、管を水平におい
ても管から流れ出すことはない。次いで検体液を
導入した管を、例えば加温器中に入れて加温し試
薬と細管内の検体液を反応させ、発色を確認した
り、管をかたむけてゲル化状態を確認したりして
検体液中のエンドトキシンの有無を容易に調べら
れる。 In such a measuring device, both ends are opened, one end is immersed in the sample liquid, and the sample liquid is introduced into the tube up to the measuring scale by capillary action or by suction with an inhaler attached to the other end, and the endotoxin detection reagent is introduced into the tube. Dissolve it in that solution. Since this detection reagent has excellent solubility in water, it is easily dissolved by simply touching the dry reagent with water. Furthermore, since the tube is thin, the sample liquid introduced in this way will not flow out of the tube even if the tube is placed horizontally. Next, the tube into which the sample liquid has been introduced is placed, for example, in a warmer to heat it, allowing the reagent to react with the sample liquid in the tube, checking for color development, and checking the state of gelation by tilting the tube. The presence or absence of endotoxin in sample fluid can be easily checked.
本考案の測定用具は上記のような構成となつて
いるため、従来の測定用具に比較してエンドトキ
シンフリーの検体液採取器を必要とせず、その採
取器による検体液の移液操作もなくなり操作が簡
便化し、更に操作中のエンドトキシンによる汚染
の危惧も減少する。さらに、検体液導入量が一定
となるため正確でしかも再現性の良い測定が出来
る。また、細管であるため測定に必要な検体液量
も少量でよく、エンドトキシン検出試薬の量も従
来に比較して少量でよい。 Since the measurement tool of the present invention has the above-mentioned configuration, compared to conventional measurement tools, it does not require an endotoxin-free sample liquid sampler, and there is no need to transfer sample liquid using the sampler. This simplifies the process and also reduces the risk of contamination with endotoxin during operation. Furthermore, since the amount of sample liquid introduced is constant, accurate measurements with good reproducibility can be performed. Furthermore, since it is a thin tube, only a small amount of sample liquid is required for measurement, and the amount of endotoxin detection reagent is also small compared to conventional methods.
本考案の検出測定用具はこの様な特長を有し、
実用上も従来の検出測定用具に比較して優れたも
のである。 The detection and measurement tool of the present invention has such features,
It is also superior in practical terms compared to conventional detection and measurement tools.
図面は本考案の１実施形を示した断面図であ
る。
１……細管、２……開口端、３……計量目盛、
４……エンドトキシン検出試薬。
The drawing is a sectional view showing one embodiment of the present invention. 1... Thin tube, 2... Open end, 3... Measuring scale,
4... Endotoxin detection reagent.
Claims (1)
管内部にエンドトキシン検出試薬を封入して成
るエンドトキシン検出測定用具。 ２ エンドトキシン検出試薬がカブトガニのアメ
イボサイトライセートである実用新案登録請求
の範囲第１項記載のエンドトキシン検出測定用
具。 ３ エンドトキシン検出試薬がカブトガニのアメ
イボサイトライセートから分離された酵素前駆
体と発色剤とからなる試薬である実用新案登録
請求の範囲第１項記載のエンドトキシン検出測
定用具。 ４ エンドトキシン検出試薬が凍結乾燥物である
実用新案登録請求の範囲第１項、第２項又は第
３項記載のエンドトキシン検出測定用具。[Scope of Claim for Utility Model Registration] 1. An endotoxin detection and measurement tool comprising an endotoxin detection reagent sealed inside a transparent capillary tube with a measuring scale and an inner diameter of 0.1 to 5 mm. 2. The endotoxin detection and measurement tool according to claim 1, wherein the endotoxin detection reagent is horseshoe crab amebocyte lysate. 3. The endotoxin detection and measurement tool according to claim 1, wherein the endotoxin detection reagent is a reagent comprising an enzyme precursor separated from horseshoe crab amebocyte lysate and a coloring agent. 4. The endotoxin detection and measurement tool according to claim 1, 2, or 3 of the utility model registration claim, wherein the endotoxin detection reagent is a lyophilized product.
Priority Applications (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP10045083U JPS608875U (en) | 1983-06-29 | 1983-06-29 | Endotoxin detection measurement equipment |
| CA000450571A CA1236396A (en) | 1983-04-01 | 1984-03-27 | Endotoxin-detecting device |
| DE8484103474T DE3472301D1 (en) | 1983-04-01 | 1984-03-29 | Endotoxin-detecting device |
| EP84103474A EP0121868B1 (en) | 1983-04-01 | 1984-03-29 | Endotoxin-detecting device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP10045083U JPS608875U (en) | 1983-06-29 | 1983-06-29 | Endotoxin detection measurement equipment |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPS608875U JPS608875U (en) | 1985-01-22 |
| JPH023169Y2 true JPH023169Y2 (en) | 1990-01-25 |
Family
ID=30237624
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP10045083U Granted JPS608875U (en) | 1983-04-01 | 1983-06-29 | Endotoxin detection measurement equipment |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPS608875U (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ATE452986T1 (en) * | 2003-03-17 | 2010-01-15 | Charles River Lab Inc | METHODS AND COMPOSITIONS FOR DETECTING MICROBIAL CONTAMINANTS |
| JP5620257B2 (en) * | 2010-12-24 | 2014-11-05 | 積水化学工業株式会社 | Microbial contaminant detection container, microbial contaminant detection system, and microbial contaminant detection method |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5582051A (en) * | 1978-12-14 | 1980-06-20 | Matsushita Electric Ind Co Ltd | Detector for deteriorated kerosene |
| JPS55159155A (en) * | 1979-05-30 | 1980-12-11 | Matsushita Electric Ind Co Ltd | Method and apparatus for identification of property of kerosene |
| JPS5641247A (en) * | 1979-09-10 | 1981-04-17 | Kanegafuchi Chem Ind Co Ltd | Polyethylene terephthalate molding composition |
| JPS573044A (en) * | 1980-06-06 | 1982-01-08 | Matsushita Electric Ind Co Ltd | Method and device for identification of kerosene characteristic |
| JPS589050A (en) * | 1981-07-10 | 1983-01-19 | Japan Organo Co Ltd | Method and apparatus for measuring content of endotoxin |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS57124392U (en) * | 1981-01-26 | 1982-08-03 |
-
1983
- 1983-06-29 JP JP10045083U patent/JPS608875U/en active Granted
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5582051A (en) * | 1978-12-14 | 1980-06-20 | Matsushita Electric Ind Co Ltd | Detector for deteriorated kerosene |
| JPS55159155A (en) * | 1979-05-30 | 1980-12-11 | Matsushita Electric Ind Co Ltd | Method and apparatus for identification of property of kerosene |
| JPS5641247A (en) * | 1979-09-10 | 1981-04-17 | Kanegafuchi Chem Ind Co Ltd | Polyethylene terephthalate molding composition |
| JPS573044A (en) * | 1980-06-06 | 1982-01-08 | Matsushita Electric Ind Co Ltd | Method and device for identification of kerosene characteristic |
| JPS589050A (en) * | 1981-07-10 | 1983-01-19 | Japan Organo Co Ltd | Method and apparatus for measuring content of endotoxin |
Also Published As
| Publication number | Publication date |
|---|---|
| JPS608875U (en) | 1985-01-22 |
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